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Preparing for the EU GMP Inspection
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Preparing for the EU GMP Inspection
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This handbook tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections.
Edition: 1st edition 2013
42 Pages
ISBN: 978-3-943267-79-2
Excerpt from the GMP MANUAL

The FDA’s GMPs and the EU’s GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two.

- The EU specifically calls for periodic reassessment of training effectiveness; the FDA does not.
- The EU allows a test-until-clean approach to cleaning validation; the FDA does not.
- EU requirements for retention of samples are more specific than the FDA’s.
- The FDA requires proof that OTC packaging is tamper resistant; EU does not.
- The FDA has requirements for a GMP audit; EU does not.

And the list goes on. If you think because you passed your last FDA inspection, you’re ready for EU inspectors, you could be sadly mistaken.

This handbook tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections.

This plain-English guide touches all the bases:

- What types of inspections EU drug regulators conduct
- The qualifications of inspectors
- The formula used by regulators for determining priority order and frequency of individual inspections
- Sample inspection documentation
- Contents of an inspection report
- Self-inspection checklist
- And much more

Table of Contents:

- About the Authors
- Inspections
- Inspectors
- Organization of Inspections
- Self-Inspection
- Inspection of Contract Manufacturers
- Inspection of Suppliers
- Preparing GMP Inspections
- Inspection of API Manufacturers
- References

Reading Sample

Preparing for the EU GMP Inspection - Reading Sample

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Dr. Michael Hiob is supervising surveillance member of the Expert Group on Qualification/Validation for the State of Schleswig-Holstein, Germany. He previously served as head of the Laboratory for Drug Analysis and GMP Inspector for the Regional Authorities for Health and Occupational Safety of the State of Schleswig-Holstein.

Max Lazar retired from Hoffman-LaRoche Inc. as VP for FDA and DEA Compliance. He now is a consultant specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance.

Dr. Christian Gausepohl heads Quality Assurance at Rottendorf Pharma GmbH. In 13+ years with Rottendorf Pharma, Dr. Gausepohl has served as coordinator of technology transfers and process optimization, head of dosage forming, production manager, and head of product transfer and process validation.

Dr. Christine Oechslein is a veteran of 23 years in drug manufacturing and development, mostly with Sandoz and Novartis. She developed oral drug delivery systems, headed a lab for development of nasal and pulmonary dosage forms, and helped create a quality manual for Rx development.
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